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Published online by Cambridge University Press: 15 June 2022
Informed consent is a central concept in the literature on the ethics of clinical care and human subjects research. There is a broad consensus that ethical practice in these domains requires the informed consent of patients and subjects. The requirements of informed consent in these domains, however, are matters of considerable controversy. Some argue that the requirements of informed consent have been inflated, others that they have not been taken seriously enough. This essay argues that both sides are partly right. To advance this argument, the essay distinguishes a general doctrine of informed consent from what it characterizes as “models of informed consent.” A general doctrine articulates a set of requirements for informed consent and then adjusts these requirements to fit the context in which they are to be applied. In contrast, different models of informed consent impose different requirements in different contexts. The essay contends that different models of informed consent are needed for clinical care and clinical research. It outlines these two models, articulates the rationale for distinguishing them, and considers and rebuts the objection that clinical care and clinical research are too deeply intertwined in contemporary medicine for the models approach to apply to them.
Center for the Philosophy of Freedom, University of Arizona, lynnjansen@email.arizona.edu. Competing Interests: The author declares none.
1 Beauchamp, Thomas, “Informed Consent: Its History, Meaning and Present Challenges,” Cambridge Quarterly of Healthcare Ethics 20, no.14 (2011): 515–23CrossRefGoogle ScholarPubMed.
2 Wertheimer, Alan and Miller, Franklin, “Preface to a Theory of Consent Transactions in Research: Beyond Valid Consent,” in Alan Wertheimer, Rethinking the Ethics of Clinical Research (Oxford: Oxford University Press, 2011), 45–115Google Scholar at 89 (italics in original).
3 Ibid. (Perhaps it would be more apt to say that Ellen in Routine Procedure has given morally transformative consent, but not informed consent, to the procedure. But I will continue to speak of informed consent to refer to both consent when one is actually informed and consent when one has been given a fair opportunity to be informed.)
4 Beauchamp, Tom and Childress, James, Principles of Biomedical Ethics, 4th edition (New York: Oxford University Press, 1994), 146–57Google Scholar.
5 The Belmont Report was written by a committee of experts selected by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It was published in 1979.
6 Belmont Report (1979).
7 It might be claimed that capacity is not a distinct element of informed consent, but a presupposition of the understanding element. One can fail to understand while having capacity, but one cannot understand while lacking capacity. But decision-making capacity may require more than the capacity to understand relevant information that is disclosed in the informed consent process. For example, it may require that one be able to appreciate the information that is disclosed. See Appelbaum, Paul, “Assessment of Patients’ Competence to Consent to Treatment,” New England Journal of Medicine 357, no.18 (2007): 1834–40CrossRefGoogle ScholarPubMed.
8 Levine, R. J., Ethics and Regulation of Clinical Research (New Haven, CT: Yale University Press, 1988)Google ScholarPubMed.
9 Looking over different models of informed consent, one might pick out the standards shared by all of them and then claim that the shared standards constitute the core of informed consent. This common core would be neither a doctrine of informed consent nor a model of informed consent and it would not provide an account of when informed consent is valid in any particular context.
10 Appelbaum, Paul and Lidz, Charles, “The Therapeutic Misconception,” in The Oxford Textbook of Clinical Research Ethics, ed. Emanuel, Ezekiel, Grady, Christine, Crouch, Robert, et al. (New York: Oxford University Press, 2008), 633–44Google Scholar.
11 Henderson, Gail E. et al., “Clinical Trials and Medical Care: Defining the Therapeutic Misconception,” PLoS Med 4, no. 11 (2007)CrossRefGoogle ScholarPubMed.
12 Exploitation, as understood in this essay, occurs when one party plays on some weakness or vulnerability of another party in order to get that party to serve his interests or ends. See Allen Wood, “Exploitation,” Social Philosophy and Policy 136 (1995). Exploitation can be done in the service of valuable ends, as when a researcher exploits trial participants to further her goal of generating knowledge to combat disease.
13 Clinical medicine does not always go well. Physicians can be incompetent, and they are subject to various principal/agent problems. I return to this issue later.
14 Jansen, Lynn A., “A Closer Look at the Bad Deal Trial: Beyond Clinical Equipoise,” The Hastings Center Report 35, no. 5 (2005): 29–36 Google Scholar.
15 Appelbaum, Paul and Lidz, Charles, “The Therapeutic Misconception in Clinical Research: Frequency and Risk Factors,” IRB 26, no. 2 (2004): 1–8 CrossRefGoogle ScholarPubMed. (I have edited this summary to remove N numbers, etc.)
16 Ibid.
17 Jansen, Lynn A. et al., “Unrealistic Optimism in Early Phase Oncology Trials,” IRB: Ethics and Human Research 33, no. 1 (2011): 1–8 Google ScholarPubMed; Jansen, Lynn A. et al., “The Impact of Unrealistic Optimism on Informed Consent to Participate in Early Phase Oncology Trials,” IRB: Ethics and Human Research 38, no. 5 (2016): 1–7 Google Scholar; Jansen, Lynn A. et al., “Variations in Unrealistic Optimism Between Acceptors and Decliners of Early Phase Cancer Trials,” Journal of Empirical Research on Human Research Ethics 12, no. 4 (2017): 280–88CrossRefGoogle ScholarPubMed. (DOI: 10.1177/1556264617720433|First Published July 21, 2017).
18 The ubiquity of biases in our everyday thinking, and their constructive as well as destructive impact on our decision-making, is a central theme of Daniel Kahneman’s influential Thinking, Fast and Slow (New York: Farrar, Straus, and Giroux, 2013).
19 What to call this additional standard? In an earlier paper I argued that biases that interfere with the rational processing of risk/benefit information could be depicted as internal voluntariness-impairing factors. See my “The Problem with Optimism in Clinical Trials,” IRB Ethics and Human Research 28, no. 4 (2006), 13–19. In that paper I sought to find a place for biases within the standard general account of informed consent. But Paul Appelbaum has persuaded me that appealing to voluntariness is not a perspicuous way to accommodate biases, since voluntariness, at least in medical ethics, has always been understood in terms of external pressures. A better name for the standard we need is appreciation. See the discussion of appreciation as an element of capacity in Thomas Grisso and Paul Appelbaum, Assessing Competence to Consent to Treatment (New York: Oxford University Press, 1998). But some care must be taken in characterizing the relevant notion of appreciation. Biases of the sort I am interested in do not undermine the capacity to consent, but they do have the potential to compromise its validity. On the view I have in mind, appreciation is like understanding. It is an element over and above capacity.
20 Veatch, Robert, The Basics of Bioethics, 2nd edition (Oxfordshire: Routledge, 2002)Google Scholar.
21 For an opposing view, see Veatch, Robert, Patient, Heal Thyself (New York: Oxford University Press, 2009)Google Scholar.
22 For discussion of the case see Faden, Ruth and Beauchamp, Thomas, A History and Theory of Informed Consent (New York: Oxford University Press, 1986), 133–38Google Scholar.
23 Disclosure requirements in clinical medicine thus could be viewed as requirements of fairness. To give a patient a fair opportunity to go forward or decline treatment, she must have access to relevant information, whether or not she actually attends to it. How much relevant information it would be fair to require physicians to disclose could vary with the type of medical decision under consideration.
24 Wertheimer and Miller, “Preface to a Theory of Consent Transactions in General,” 105.
25 Imagine a research participant who resembles the patient Ellen in Routine Procedure. She is willing to consent to participate in a trial, has been given a fair opportunity to become informed about it, but does not want to be informed. Suppose that she should not be enrolled if the researcher conducting the trial knows that she is not informed. This is well explained on the autonomous authorization view, but hard to account for on the fair opportunity view. For this research participant like Ellen has been given a fair opportunity to become informed. For further discussion of this issue see my “Taking Respect Seriously: Clinical Research and the Demands of Informed Consent,” Journal of Medicine and Philosophy 43, no. 3 (2018): 342–60.
26 Earlier versions of the Declaration of Helsinki (1964 and 1975) had separate guidelines for “Medical Research Combined with Professional Care (Clinical Research)” and “Non-therapeutic Biomedical Research Involving Human Subjects (Non-Clinical Biomedical Research).” The former category clearly manifests the intertwinement of medicine and research.
27 The classic—and still very relevant —discussion of this problem is Fried, Charles, Medical Experimentation: Personal Integrity and Social Policy (New York: American Elsevier, 1974)Google Scholar.
28 Dresser, Rebecca, “The Ubiquity and Utility of the Therapeutic Misconception,” Social Philosophy and Policy 19, no. 2 (2002): 271–94CrossRefGoogle ScholarPubMed.
29 Miller, Franklin and Rosenstein, D., “The Therapeutic Orientation to Clinical Trials,” New England Journal of Medical Ethics 348 (2003): 1383–86CrossRefGoogle ScholarPubMed.
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31 Sreenivasan, Gopal, “Does Informed Consent to Research Require Comprehension?” Lancet 326 (2003): 2016–18CrossRefGoogle Scholar.
32 The benefit part of the risk/benefit profile must be assessed relative to an appropriate baseline. Sometimes the appropriate baseline is the risk/benefit profile provided by an alternative intervention, other times it is the likely outcome of receiving no intervention at all. Thus, a very risky procedure with only a small prospect for benefit can be favorable relative to the no-treatment baseline, which presents very grim prospects. Context should determine what baseline is the appropriate one.
33 Miller, Franklin and Joffe, Steven, “Benefit in Phase One Oncology Trials: Therapeutic Misconception or Reasonable Treatment Option?” Clinical Trials (2008): 617–23CrossRefGoogle ScholarPubMed.
34 Bromwich, Danielle and Rid, Annette, “Can Informed Consent Be Adapted to Risk?” Journal of Medical Ethics 41 (2015): 521–28CrossRefGoogle ScholarPubMed.